Social Robot Interaction on Fear and Pain Levels in Children
The Effect of Social Robot Interaction on Fear and Pain Levels in Children During Venous Blood Sampling: A Randomized Controlled Study
The goal of this clinical trial is to compare the effectiveness of social robot interaction and digital game-based distraction in reducing fear and pain during venous blood sampling in children aged 4-12 years with chronic diseases.
The main questions it aims to answer are:
- Does social robot interaction reduce procedural fear and pain more effectively than standard care during venous blood sampling?
- Does social robot interaction provide greater emotional recovery after the procedure compared with digital game-based distraction and standard care? Researchers will compare a social robot intervention group, a digital game-based distraction group, and a standard care group to determine their effects on children's fear and pain levels before, during, and after venous blood sampling.
Participants will:
- Be randomly assigned to one of three groups: social robot, digital game, or standard care.
- Complete fear and pain assessments 5 minutes before, during, and 5 minutes after the venous blood sampling procedure.
- Interact with a social robot or play a digital game before and during the procedure if assigned to one of the intervention groups.
- Receive routine clinical care if assigned to the standard care group. The study aims to provide evidence on the effectiveness of technology-based distraction methods for reducing procedural distress and improving the procedural experience of children undergoing venous blood sampling.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34010
- Koc University
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children aged 4-12 years
- Clinical indication for venous blood sampling
- Ability to communicate in Turkish
- No cognitive disabilities
- No sensory disabilities
- Parent or legal guardian provides informed consent
- Child provides verbal assent
Exclusion Criteria:
- Requirement for emergency medical intervention
- Use of analgesic medication within 6 hours prior to the procedure
- Diagnosis of developmental delay
- Previous participation in a social robot-based intervention or study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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간섭 없음: 대조군
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실험적: social robot
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Children interacted with an interactive social robot for approximately 5 minutes before venous blood sampling and throughout the procedure.
The robot provided age-appropriate storytelling, songs, verbal communication, movement-based interaction, and visual stimulation to distract children and reduce procedural fear and pain.
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실험적: digital game
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Children received a digital game-based distraction intervention using the Bubble Rainbow application.
Participants were allowed to familiarize themselves with the game for approximately 5 minutes before venous blood sampling.
During the procedure, children continued playing the game on a tablet device while receiving support from their parents.
The game included interactive activities such as bubble popping, color matching, and visual attention tasks designed to engage the child's attention and reduce procedural fear and pain.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Wong-Baker Faces Pain Rating Scale
기간: Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale.
The scale consists of six facial expressions scored from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity
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Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Children Fear Scale
기간: Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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Procedural fear was assessed using the Scary Scale, a self-report instrument designed for children aged 4-12 years.
The scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear), with higher scores indicating greater fear levels.
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Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Lakatos G, Gacsi M, Konok V, Bruder I, Bereczky B, Korondi P, Miklosi A. Emotion attribution to a non-humanoid robot in different social situations. PLoS One. 2014 Dec 31;9(12):e114207. doi: 10.1371/journal.pone.0114207. eCollection 2014.
- Fox J, Gambino A. Relationship Development with Humanoid Social Robots: Applying Interpersonal Theories to Human-Robot Interaction. Cyberpsychol Behav Soc Netw. 2021 May;24(5):294-299. doi: 10.1089/cyber.2020.0181. Epub 2021 Jan 11.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 1 (Mobile Health and Wellness Program)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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